Senior Principal Statistical Programmer

🕒 Setembro 29

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $152.000 - $190.000 / ano

⏰ Tempo Integral

🟠 Sênior

🖥 Engenheiro de Software

👻 Score fantasma 4%

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🗣️🇺🇸🇬🇧 Inglês obrigatório

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Iambic Therapeutics

51 - 200 funcionários

Fundada em 2019

🏥 Saúde

💼 Consultoria

🏭 Manufatura

💰 Series B em 2024-04

Healthcare • Consulting • Manufacturing

A Iambic Therapeutics é uma empresa de biotecnologia pioneira que utiliza algoritmos avançados de IA para a descoberta de medicamentos. Sua plataforma experimental inovadora e de alta capacidade visa atender necessidades não atendidas de pacientes otimizando moléculas para diversos alvos terapêuticos. A abordagem impulsionada por IA da empresa permite explorar rapidamente espaços químicos, revelando novos mecanismos de medicamentos e fornecendo leads de alta qualidade em um ritmo acelerado em comparação com métodos tradicionais.

Descrição

• Lead the design, development, validation, and maintenance of SAS programs generating SDTM, ADaM, and TLFs • Ensure compliance with CDISC standards, FDA/EMA regulatory guidelines, and internal SOPs • Collaborate with Biostatisticians, Data Managers, and Clinical Operations teams to define programming requirements and timelines • Perform quality control and peer review of deliverables • Act as the technical subject matter expert on statistical programming • Mentor junior programmers • Support preparation of clinical study reports, regulatory submission packages including eCTD and ISS/ISE, and responses to regulatory agencies • Develop and refine departmental processes, templates, and tools • Contribute to vendor oversight and provide technical leadership for outsourced programming activities • Interface and collaborate with data science and machine learning groups to bridge clinical and AI infrastructure • Support statistical programming activities for clinical trials from Phase I through regulatory submission

🎯 Requisitos

• Bachelor's or Master's degree in Computer Science, Statistics, Mathematics, Life Sciences, or a related field • Minimum of 10 years of experience in statistical programming in the pharmaceutical, biotechnology, or CRO industry • Oncology experience preferred • Proficiency in SAS/Base, SAS/Macro, SAS/SQL, and SAS/Graph • Familiarity with Python preferred • Strong experience with CDISC standards (SDTM and ADaM) • Familiarity with define.xml and Pinnacle 21 • Experience supporting regulatory submissions to FDA and/or EMA • Excellent problem-solving skills and attention to detail • Ability to work independently and as part of a cross-functional team • Exposure to cloud-based data systems or programming in a validated GxP environment preferred • Currently authorized to work in the United States • Must answer whether visa sponsorship will be required now or in the future

🏖️ Benefícios

• Company-paid healthcare • Flexible spending accounts • Voluntary life insurance • 401K matching • Uncapped vacation • Onsite gym • Onsite dining • Brand-new state-of-the-art facility

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